Health Canada OKs Ivacaftor for Cystic Fibrosis Patients Down to 2 Months
Health Canada granted market authorization for the expanded use of ivacaftor to treat cystic fibrosis in certain children ages 2 months and older.
Category: Intl’ Pharmaceuticals
Intl' Pharmaceuticals
Latest
Intl' Pharmaceuticals
Latest
COVID-19 Outpatients Do Not Benefit from Aspirin, Colchicine
A randomized trial of nearly 4,000 outpatients with COVID-19 found no benefit from treatment with aspirin or colchicine, according to research presented at ESC Congress 2022.
Intl' Pharmaceuticals
Latest
Canada Authorizes Novavax COVID-19 Vaccine for Adults
Health Canada has granted authorization for Novavax Inc's COVID-19 vaccine "Nuvaxovid" for adults age 18 and older.
Merck to License COVID-19 Antiviral to Drugmakers in Other Companies
Merck has entered into a voluntary licensing agreement to allow the production of its investigational COVID-19 antiviral molnupiravir by drugmakers in 105 low- and middle-income countries.
Read More
Novavax Pursuing UK Authorization for COVID-19 Vaccine
Novavax has completed its rolling regulatory submission for authorization of its NVX-CoV2373 COVID-19 vaccine candidate in the United Kingdom.
Read More
Positive Data for Valneva COVID-19 Vaccine
The French pharmaceutical company Valneva announced positive topline results from the Phase 3 trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
Read More
Moderna Booster Vaccine Induced Antibody Responses Against Delta Variant
Moderna’s COVID-19 vaccine booster (mRNA-1273 50µg dose level) induced robust antibody responses of more than 40 times against the Delta variant (B.1.617.2), according to Phase 2 clinical data reported by the company.
Read More
Clinical Trial Begins for 2nd-Gen COVID-19 Vaccine
A Phase I/II clinical trial in the Netherlands will test AKS-452, a COVID-19 vaccine candidate that is shelf-stable for at least 4 months without refrigeration.
Read More
Six Months of Data Show 91.3% Efficacy for Pfizer Vaccine in Adults
Updated Phase 3 data analyzing the Pfizer-BioNTech COVID-19 vaccine up to six months after second vaccination showed it was 91.3% effective overall and 100% effective versus severe disease.
Read More
Pfizer Vaccine Effective, Well-tolerated in Adolescents, Company Says
Results of a Phase 3 trial of Pfizer/BioNTech’s COVID-19 vaccine demonstrated a 100% efficacy and robust antibody responses in participants aged 12-15 years old, according to the company.
Read More
Moderna, Pfizer Vaccines Proving 90% Effective
The CDC reports risk of COVID-19 infection following the second dose of Moderna or Pfizer’s vaccine was reduced by 90% two or more weeks after vaccination.
Read More
Kaftrio One Step Closer to EU Expanded Approval for Cystic Fibrosis Patients
The European Medicines Agency’s CHMP adopted a positive opinion for a label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for certain cystic fibrosis patients.
Read More
AstraZeneca Vax 76% Effective Overall, 100% Prevention of Severe Disease
New data released by AstraZeneca Thursday report its vaccine was 76% effective at overall prevention of symptomatic COVID-19, 85% effective in adults 65 and older, and 100% effective in preventing severe or critical disease and hospitalization.
Read More
Safety Board Expresses ‘Concern’ Over AstraZeneca Vaccine Data
A Data & Safety Monitoring Board expressed concern that AstraZeneca may have included outdated information in a Phase 3 trial for its COVID-19 vaccine.
Read More
AstraZeneca COVID-19 Vaccine 79% Effective in Adults
AstraZeneca says it will submit its COVID-19 vaccination for FDA authorization after phase 3 trial results found the vaccine to be 79% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe disease and hospitalization.
Read More